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Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial

Join the TIME Trial: Immunotherapy for Advanced Melanoma.

Recruiting
18 years and older
All
Phase 2

This study is for people with advanced melanoma (a type of skin cancer) that can't be removed by surgery or is stage IV. The study looks at how well two drugs, ipilimumab and nivolumab, work when given at different times of the day. These drugs help the body's defense system fight the tumor. Some patients benefit from them, but many do not. Scientists want to see if giving these drugs in the morning helps more people.

  • This study lasts up to 2 years, with regular follow-ups for up to 5 years.
  • Patients must visit every 3 weeks for drug cycles and have various tests like blood samples and scans.
  • Participation is for adults (18+) with specific types of melanoma.

During the study, patients will be split into three groups, each getting the drugs at different times: morning, midday, or afternoon. The goal is to find out if the time of day affects how well the drugs work and if they help improve survival. Participants will be monitored closely, and some may have optional tumor biopsies. After study treatment, follow-up continues every 3 months for a year, then up to 5 years.

Study details
    Advanced Acral Melanoma
    Advanced Cutaneous Melanoma
    Advanced Mucosal Melanoma
    Clinical Stage IV Cutaneous Melanoma AJCC v8
    Metastatic Acral Melanoma
    Metastatic Cutaneous Melanoma
    Metastatic Mucosal Melanoma
    Unresectable Acral Melanoma
    Unresectable Cutaneous Melanoma
    Unresectable Mucosal Melanoma

NCT07155317

Emory University

5 September 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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